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HemosIL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP] Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

HemosIL LA Negative Control is intended for use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

HemosIL LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a pooled normal plasma with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.

HemosIL LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.

The provided text describes a 510(k) premarket notification for the HemosIL LA Positive Control & HemosIL LA Negative Control, primarily focusing on establishing a new reconstituted frozen stability claim. The submission aims to demonstrate substantial equivalence to a previously cleared device (K110031) with this added claim.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a test set used to prove the new stability claim. It also does not specify the provenance of any data used for this specific stability study (e.g., country of origin, retrospective or prospective).

The submission focuses on a new stability claim for existing controls, implying that tests would have been performed to validate this. However, the details of these tests (such as the number of control vials tested, the number of measurements taken, or the specific experimental design) are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For a quality control product like this, "ground truth" typically refers to the confirmed stability characteristics and performance of the control. The establishment of such ground truth would typically be done through controlled laboratory studies and adherence to established quality control guidelines, rather than by expert consensus in the way clinical diagnostic devices might.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a quality control product and the type of performance characteristic being evaluated (stability), an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1, is unlikely to be relevant or applicable. Performance would be assessed against predefined analytical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and not provided. The device is a quality control material for in vitro coagulation studies, not an AI-assisted diagnostic tool or an imaging device that involves human reader interpretation. Therefore, an MRMC study or a comparison of human reader performance with and without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a laboratory control, not an algorithm. Its performance is evaluated analytically, not as a standalone algorithm.

7. The Type of Ground Truth Used

For the specific new claim being made (reconstituted frozen stability), the "ground truth" would be established through analytical testing and measurements of the control's performance over the specified stability period (3 weeks at -20°C). This would involve measuring the control's activity or characteristics using the target LA assays and instruments, and demonstrating that these measurements remain within pre-defined acceptable ranges throughout the claimed stability period. The document refers to "Performance Characteristics M. Analytical performance" and "c. Traceability, Stability, Expected values (controls, calibrators, or methods)" as sections where these details would typically be found, stating "Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial."

8. The Sample Size for the Training Set

This information is not provided. As a quality control product, the concept of a "training set" in the context of machine learning algorithms is not applicable here. The development and manufacturing of the control would involve process validation and extensive quality control testing, but not a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the reasons stated in point 8.

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• HemosIL LA Positive Control .
  For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Negative Control
  For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Positive Control
  The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• HemosIL LA Negative Control
  The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

The provided text describes a 510(k) summary for the HemosIL LA Positive Control and HemosIL LA Negative Control devices. These devices are quality controls for Lupus Anticoagulant (LA) assays performed on specific IL Coagulation Systems. The study presented aims to demonstrate the precision of these control devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Note: The "Conclusion" section explicitly states: "All results were well within specification for both lots of controls tested." The tables provided show detailed CV% values, all of which are below 6% for both within-run and total precision across various instruments and reagents.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: N=80 (2 replicates per run / 2 runs per day / 20 days) for each of two lots of each control level, with two different LA assays per instrument platform.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective study as it describes a specific experimental protocol for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This study is evaluating the precision of quality control materials for an in-vitro diagnostic device, not an interpretation of images or clinical data by experts. Therefore, the concept of "ground truth established by experts" as typically understood in AI/medical imaging does not directly apply here. The "ground truth" for these controls is their expected value (positive or negative for LA) and their performance characteristics against established quality standards (precision).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described as this is a laboratory assay precision study, not a study involving human interpretation with potential discrepancies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an MRMC comparative effectiveness study. It's a precision study for diagnostic controls.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this is a standalone performance study. The devices (quality controls) are tested on automated coagulation systems. There is no human interpretation or "human-in-the-loop" component being evaluated beyond the inherent operation of the lab instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for these controls is their known characteristics:

• HemosIL LA Positive Control: Lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies, confirmed positive for LA according to ISTH Guidelines.
• HemosIL LA Negative Control: Lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma, recommended as a negative control for LA by ISTH Guidelines.

The performance of the controls is then measured against a precision specification (≤ 6% CV).

8. The sample size for the training set

This document does not describe the development of an algorithm or AI. It describes the performance evaluation of quality control materials. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

As there is no training set for an algorithm, this question is not applicable. The "ground truth" for the controls themselves (their positive or negative status) is established by their formulation and adherence to established guidelines (ISTH).

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